Surgical Transversus Abdominis Plane Block in Pediatric Patients (TAP)

This study is currently recruiting participants.
Verified July 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01548027
First received: March 5, 2012
Last updated: July 4, 2012
Last verified: July 2012
  Purpose

The objective of this study to determine the effect of surgical transversus abdominis plane block and local infiltration for postoperative pain control in major abdominal surgery compare with control group.


Condition Intervention
Child
Procedure: Local infiltration group
Procedure: TAP block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Surgical Transversus Abdominis Plane Block for Postoperative Pain Relief Following Abdominal Surgery in Pediatric Patients.

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • opioids consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    total opioids consumption in first 24 hours postoperatively


Secondary Outcome Measures:
  • Time to first analgesic [ Time Frame: 24 hr ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: March 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
no injection of local anesthetic agents
Experimental: Local infiltration group Procedure: Local infiltration group
patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.
Other Name: local anesthetic infiltration
Experimental: TAP block group Procedure: TAP block
Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months
Other Name: surgical transversus abdominis plane block

Detailed Description:

Most children experience postoperative pain after major abdominal surgery. They may have ineffective ventilation, following atelectasis and pneumonia if receive inadequate pain management. There are several methods used for pain relief such as epidural block, intravenous analgesia with local infiltration, transversus abdominis plane (TAP) block by ultrasound guided and surgical TAP block. Therefore, the investigators would like to compare the effectiveness of postoperative pain control with TAP block. However, TAP block in children need experience and ultrasound. The investigators decided to do surgical TAP block performing by inject from peritoneum point to skin instead.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age < 15 year
  2. ASA I-III
  3. Abdominal surgery : all upper abdomen and lower abdomen which would have midline incision
  4. Elective surgery

Exclusion Criteria:

  1. Allergic to Lidocaine or bupivacaine
  2. Delayed development
  3. Major abdominal surgery within 2 year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548027

Contacts
Contact: Saowaphak Lapmahapaisan, M.D. 662-4197995 sislg@mahidol.ac.th

Locations
Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Saowaphak Lapmahapaisan, M.D.    662-419-7995    sislg@mahidol.ac.th   
Principal Investigator: Saowaphak Lapmahapaisan, M.D.         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Saowaphak Lapmahapaisan, M.D. Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01548027     History of Changes
Other Study ID Numbers: 752/2554
Study First Received: March 5, 2012
Last Updated: July 4, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
TAP block
postoperative analgesia

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014